SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Date 01/01/1901 |
Event Type
Injury
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Event Description
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It was reported in a register report from eprd (endoprothesenregister deutschland) that there were four revision surgeries performed to replace the insert implant genesis ii dished and the genesis ii ldk cocr femoral component due to unspecified reasons.There is no additional information about the hospital, patient, and surgery data.The eprd provided this information as part of a cumulative statistical study regarding failure frequency.This report states that there have been 17 revision surgeries, however we received on 17-feb-2021 a previous report with 13 revision surgeries which were covered under case-2021-00042184 / fda report number: 1020279-2021-02103 / bfarm reference: 03986/21.Based on this information, we report the remaining 4 revision surgeries in the present complaint.
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).
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Manufacturer Narrative
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation, as the data was reported in a register report from eprd (endoprothesenregister deutschland) that there were four revision surgeries performed to replace the insert implant and the femoral component due to unspecified reasons.There is no additional information about the hospital, patient, and surgery data.The eprd provided this information as part of a cumulative statistical study regarding failure frequency.Per case details, no further information is available.Therefore, based on insufficient information, further clinical root cause analysis cannot be performed.The current condition of each patient is unknown and the patient impact beyond the reported events could not be determined.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Internal complaint reference number: case (b)(4).
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